NCT06024967尚未招募3 期
The Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency: An Open-label, Single-arm, Multicenter Phase 3 Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 180
- 主要终点
- Adverse Events of once-weekly GenSci004 in children with GHD
研究概览
简要总结
The purpose of this Phase 3 study is to evaluate the safety and efficacy of once-weekly GenSci004 over 108 weeks in children with GHD aged from 6 months to 17 years old, inclusive.
详细描述
The purpose of this Phase 3 study is to evaluate the safety and efficacy of once-weekly GenSci004 over 108 weeks in children with GHD aged from 6 months to 17 years old, inclusive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Investigator-determined diagnosis of GHD prior to the historical initiation of daily rhGH trerapy
- •Participant must be 6 months to 17 years old
- •Tanner stage <5 at Visit 1
- •Open epiphyses
- •Normal fundoscopy at Screening
- •Written, signed, informed consent of the participant's parent(s)/LAR(s) and written assent of the participant
排除标准
- •History or presence of malignant disease
- •Children with diabetes mellitus
- •Major medical conditions and/or presence of contraindications to GH treatment
- •Participation in any other study of an investigational agent within three months prior to Visit 1
- •Prior exposure to investigational drug or any other long-acting growth hormone
- •Any other reason per investigator's discretion
研究组 & 干预措施
GenSci004
Experimental
干预措施: PEG-somatropin (Drug)
结局指标
主要结局
Adverse Events of once-weekly GenSci004 in children with GHD
时间窗: 108 weeks
Incidents of adverse events
次要结局
- Annualized Height Velocity (AHV)(104 weeks)
研究者
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